Cleared Traditional

DynamicIQ

K222895 · GE Medical Systems SCS · Radiology
Nov 2022
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K222895 is an FDA 510(k) clearance for the DynamicIQ, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on November 22, 2022, 60 days after receiving the submission on September 23, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K222895 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2022
Decision Date November 22, 2022
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

Similar Devices — KPS System, Tomography, Computed, Emission

All 468
uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)
K253564 · Shanghai United Imaging Healthcare Co., Ltd. · Feb 2026
VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)
K254001 · Spectrum Dynamics Medical, Ltd. · Jan 2026
AnyScan 3.0 NM Scanner Family
K253844 · Mediso Medical Imaging Systems, Ltd. · Dec 2025
Cartesion Prime (PCD-1000A/3) V10.21
K251370 · Canon Medical Systems Corporation · Dec 2025
PennPET Explorer Positron Emission Tomograph
K251401 · Trustees of the University of Pennsylvania · Nov 2025
Hybrid Viewer (00859873006240)
K252477 · Hermes Medical Solutions AB · Sep 2025